Barış Erdoğan, CEO of Clinerion, sat down with me to explore how medical data informatics and real-world electronic health record (EHR) data can be used to improve the efficiency and effectiveness of patient searches, identification, and recruitment; clinical trials; and drug development in order to ensure earlier availability of medicines.
Here is a sneak peek of our conversation:
Q: For a pharmaceutical company about to launch a new oncology product or a new biotech company, what is the step-by-step process that you go through so that you can help them get their protocol or their clinical trial off to a good start?
A: We start with an analysis of the real-world data to understand how many patients would be available in the real-world setting, so that they can optimize their criteria in terms of selection and their experimental settings. We help them to optimize their criteria and help them see the effect of every criterion by playing around across the world to see the population that they are targeting. This is extremely important in order to reduce protocol amendments because when trial protocols do not help the physicians to find patients, if they have strict criteria, then an amendment is inevitable and this causes delays in the whole process. If–in the very beginning–the protocol is correctly designed, this will help them to save a lot of time.
Secondly, we help them to show the potential across many countries; how many patients they could expect to enroll, and then where these patients could be enrolled. If these countries are of interest, then we show which healthcare organizations would have the highest volume of eligible patients and then they can also see their past performance at these sites. They are ongoing trials, completed trials, and if there are any competing trials at the site, they can also see that.
When everything is done–the sites are selected, the contracts are in place, all the regulatory work is finalized–the patient finder tool at the site is activated. All these participating principal investigators can have access to this tool securely within their infrastructure, within their healthcare organizations, go into the details of all the eligible patients, and tag them whether they’re truly eligible or if there is any problem from the data that comes in.
If everything is alright, they just enroll the patient, and of course, if it’s a healthcare group or if they have collaborating hospitals across their city or region, they can enable patient referrals. This is also important for patients that are missing treatments and that are not able to tap into these innovative treatments, so they can still enable the referral of these patients to the right trial sites and help them get the right treatment…
For more of our discussion, you can watch the whole Fireside Chat with Barış Erdoğan, or listen to the podcast version, below.
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